To gain FDA approval for widespread use, a new treatment must successively pass three phases of clinical trials, each seeking to answer different questions:

Phase I: Is a new treatment safe? What are safe dosage levels? Usually small trials, often with less than a dozen patients.Phase II: How well does the treatment work? What are its side effects? (Adriana Jenkins is in a Phase II trial.)Phase III: Does the treatment heal more effectively than standard treatments? Does it work consistently in a large group of patients? This phase often involves hundreds of patients in many hospitals.

HERCEPTIN

About 30 percent of breast cancers produce excessive HER-2 proteins, which makes cancer cells proliferate. Herceptin disables HER-2. It hits only HER-2 producing cancer cells, not normal cells, minimizing side effects and earning it the title "smart" drug. UCLA's Dennis Slamon spent 13 years developing Herceptin. San Franciso-based Genentech Inc. sells it. The first large-scale clinical trial results came out in May 1998: 78 percent of patients on Herceptin plus chemotherapy survived one year; compared to 67 percent on chemo alone. The FDA approved Herceptin for treating metastatic breast cancer, where the cancer has spread. Doctors now seek to extend its use to earlier stages of cancer through clinical trials, such as the one involving Adriana Jenkins.

The Globe followed breast cancer patient Adriana Jenkins through a clinical trial at the Dana Farber Cancer Institute in Boston for eight months. A reporter and photographer were given access to most medical events and records. All conversations reported were witnessed. The lengthier exchanges that appear in the stories were recorded on audio tape. Jenkins' writings, as well as representations of her thoughts, were taken from contemporaneous notes written by her and supplied to the Globe on a regular basis throughout the eight months.

ope.

The word is tattooed on Adriana Jenkins's wrist, in black ink and flowing cursive script. Her battle against a deadly cancer once proliferating in her breast inspired it.

It is small enough to be obscured by her watch band. No garish tattoos for Jenkins: There remains a career and marriage and social life to consider. Still, she stares at it most every day.

"This is my life now," she said, lounging at a Brookline cafe in the late morning on a recent weekday. "I am a cancer patient."

In April, the Globe chronicled 32-year-old Adriana Jenkins's journey through a clinical trial for an experimental cancer therapy. The therapy appeared to work: Her massive tumor disappeared. However, she developed a mild heart problem as a side effect, prompting doctors to pull her from the trial seven months into the scheduled 15-month experiment.

In the four months since the Globe stories appeared, Jenkins has finished chemotherapy and completed radiation treatment. Some hair has grown back. The heart problems vanished. Her cancer has not returned.

As a test subject, Jenkins exemplified the risks and promise of clinical trials, a central piece in the mission of Boston's world-leading medical community. Today, her role in the experiment over, she faces a new struggle: the transition from a medical test subject facing death to a cancer survivor reconstructing life. "In my mind, if I make it two more years, that'll be a big hurdle for me," she said.

The cancer is gone, but it is not forgotten. Her doctors say a 60 percent chance remains that it will return within four years. Early death remains a possibility; doctors aren't likely to ever pronounce her "cured."

For now, Jenkins is well. A thick, kinky wave of mostly gray hair recently sprouted on her once-bald head. She dyes it jet black. Loose clothing and special undergarments mask the fact that a scar exists in place of her right breast. "She's doing well. She has now completed all of the chemo. She's recovering strength, growing hair," said Dr. Jennifer Ligibel, her doctor at the Dana-Farber Cancer Institute. "She's in the rebuilding phase."

During the trial, Jenkins's heart began beating irregularly. Doctors also found that her heart's pumping strength slightly less ened. Both problems disappeared once she stopped taking Adriamycin, a harsh chemotherapy drug. Jenkins has resumed taking Herceptin, the so-called "smart drug" that was the trial's focus. Researchers designed the virtually side-effect-free drug to target specific cancers, avoiding the indiscriminate cellular destruction that makes many cancer therapies harrowing. She has had no recent heart problems, despite restarting Herceptin. Her doctors remain puzzled over the precise cause of the earlier problems.

On July 12, she completed her intensive treatment at Dana-Farber with the last of 33 exhausting blasts of radiation therapy. She also recently started a five-year course of tamoxifen, a drug that blocks certain cancer cells from feeding off female hormones.

"We hope [her cancer] is gone forever, but we watch carefully," said Ligibel. "The longer period of time that has passed, the more likely this will never come back."

On July 10, Jenkins marked one year since her cancer diagnosis. She went out for dinner with her husband, David Halligan. They plan to celebrate one year of marriage on Sept. 15.

He has been a pillar in her life, one that she increasingly leans on. He found new work with manageable hours in part to spend more time with her. And he never once complained about marrying a woman facing death and lacking a breast and hair and, on many days, energy. Jenkins worked throughout her trial in the public relations department at Millennium Pharmaceuticals in Cambridge. But this summer, a deep weariness finally set in. She left work, taking paid medical leave. She began resting her tired, scarred, chemotherapy-battered body.

She sleeps now. A lot. She has taken up painting, favoring color-filled abstract work.

"It's been great just to relax, take a break, go at a pace my body is comfortable with," she said.

A simple headache still prompts fear. A brain tumor, perhaps? But, during the tranquillity of the summer, a transformation occurred. "I crossed some line where I'm not obsessed with it all the time," she said. "It was exhausting to constantly be contemplating my demise."

After the Globe series appeared in April, Jenkins received an outpouring of support and concern, from friends, colleagues, other cancer patients, and even strangers. In the tears and hugs, she saw energy waiting to be harnessed. And so she fashioned a new role for herself: activist.

She has organized an art auction to benefit breast cancer research at the Tufts-New England Medical Center. The Boston Harbor Hotel donated a ballroom. Christie's auction house will run the event. Already, more than 60 artists, mostly local, have donated work, including amateur painter Senator Edward M. Kennedy. Channel 5 news anchor Natalie Jacobson will be the master of ceremonies. The effort -- Jenkins dubbed it "Art for Hope" -- has already received $31,000 in corporate donations, including one from San Francisco-based Genentech Inc., the maker of Herceptin. Her goal for the Oct. 3 event is $100,000.

On a recent morning, she surveyed the ballroom, with its sweeping views of the Boston waterfront. Where should the food table be, she asked, walking around the room, pointing left and right, tailed by several public relations people. Where should the jazz band sit? What about coat check? And reception?

Four of Jenkins's paintings, completed this summer, will be auctioned. One is of a pink tree, using the color adopted by breast cancer activists. Another portrays a child's silhouette.

"This is fun," she said, laughing. "Maybe I'll do it every year."

Clinical trials have taken a battering in recent years, after a 1999 gene therapy trial in Pennsylvania ended with a teenager's death. A recent Time magazine issue with a story on clinical trials depicted on its cover a frightened patient in an animal cage. But Adriana Jenkins holds another opinion: "The clinical trial saved my life."

"Art for Hope" is her expression of gratitude to the research community. But after the auction has ended and the jazz band has sounded its last note, Jenkins will return home with her husband to continue life as a cancer patient. It is a precarious life, but she has come to see it as a deeply enriched one. And, with each passing day, it molds Jenkins's identity anew.

"I think I have slowly learned to mesh my old life with this new one with some success, and hopefully as time goes on, I will recapture more and more of my old life," she said.

"But this life has some benefits as well. People reach out to you in all sorts of wonderful ways. I have learned to appreciate people and things in a completely new way."

For information on "Art for Hope," call the Tufts-New England Medical Center's development office at 617-636-7656.